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Hear From the Experts - Regulatory & Quality Consulting - Regulatory

To learn more about a particular aspect of Quintiles’ pharma services, biotech development or drug commercialization services, select a topic at left. If you’ve already specified a choice, you may narrow your search by selecting additional categories in any order. For example, for information on oncology drug development, start by selecting oncology. Then you can narrow your search to Central Lab, News Releases and Europe.

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  • Communication Strategies for Risk Minimization

    July 12, 2010
    In the US, the Food and Drug Administration (FDA) approves pharmaceutical products based upon the results of adequate, wellcontrolled clinical studies demonstrating that each product

  • Generic Drug Approvals in the US Prior to the Hatch-Waxman Act

    July 12, 2010
    It is a common misconception that the Hatch-Waxman Act of 1984 created the generic drug approval process in the US. A recent article claimed there were

  • The Evolution of Oncologic Drug Development

    July 8, 2010
    Despite a doubling in the number of candidates in the cancer drug pipeline from 1990 through 2006, the overall US approval rate for cancer drugs

  • FDA Requirements for Clinical Studies in Pediatric Patients

    July 7, 2010
    Differences in the physiology of adults and children can produce significant differences in the way they respond to drugs and vaccines. Without adequate data on pediatric

  • On the Origin of the Animal Rule

    July 7, 2010
    New Drug and Biological Drug Products; Evidence Needed to Demonstrate Effectiveness of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible

  • Key Challenges to US Topical Ocular Drug Development

    July 7, 2010
    This article examines five key facets of the topical ocular drug industry to highlight key challenges associated with ocular drug development. An understanding of ophthalmology

  • Follow-on Biologics in the EU & US

    July 7, 2010
    Follow-on biologic (FOB) is the generally accepted terminology, although “biogeneric” is often favored by the generic drug industry. European and Canadian regulatory agencies refer to

  • CMC, Preclinical and Clinical Considerations for Biosimilars and Follow-on Biologics

    July 7, 2010
    This article summarizes some of the issues pertaining to biosimilars in Europe that are also likely to impact eventual FOB approval testing in the US.

  • Geoff Garabedian

    March 25, 2009
    As Practice Leader for Regulatory and Quality in the U.S., Geoff combines a strong management consulting background with specific experience in the regulatory and compliance arena, including design and implementation of large-scale process, organization and technology transformations.

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